The CMC Program Management Lead is responsible for leading cross-functional teams within Technical Development & Operations on multiple projects from inception through completion, coordinating activities to develop the physical product, manufacturing process, supply chain and regulatory files for successful launch and ongoing commercial supply.
In this role, the incumbent will help build, grow, and mature the CMC function. This individual must possess strong communication skills and must be savvy working with Research, technology, process development, analytical development, manufacturing, clinical, medical and regulatory and business partners across the organization in a collaborative way.
They will also prepare project team and senior leadership meeting materials related to their assigned projects and ensure project work complies with established practices, policies, and processes. Project issues and risks must be identified and tracked, and plans to resolve these issues must be developed and solutions executed.
Reporting to Head of Technical Strategy & Operations this position is accountable for the successful and timely completion of projects including:
- Definition and management of product CMC and lifecycle strategy as required
- Delivery of CMC activities up to and including new product launch and post launch improvements.
- Process development, Scale-up, Technology Transfer, Assay development and Transfer as required
- Process Improvements
- Risk mitigation plans
Describe the essential daily job functions and include % of time spent on each.
% of Time
Job Function and Description
Accountable for defining and successfully delivering aspects of the CMC and supply chain strategy for a specific product along with obtaining and managing required resources and budget.
Leads matrix teams and coordinates activities across Technical Development & Operations and functions in Research, Development, Quality Clinical and Regulatory, Project Management, (including external partners) to develop the physical product, the manufacturing process, establish the supply chain and deliver the regulatory files, clinical studies, successful launch and ongoing commercial supply.
Supports development of an integrated CMC/supply chain strategy and plan. Represents the Technical function on respective Candidate and Asset teams. Provides input to the overall lifecycle strategy of the product.
Ensures the principles of operational excellence and risk management are applied
Ensures compliance with Spark’s policies and procedures on development and supply of the physical product, the technical governance, including identification, assessment, escalation and management of technical risk as the product is commercialized and throughout its lifecycle.
Responsible for successful strategic project execution & delivery, team management, governance, prioritization, resource planning, execution tools, training and monthly reporting as they apply to assigned projects and new and improved processes.
Coordinates with teams in Research, Development, Quality and Clinical, & Regulatory and ensures the Technical Operations Team is aware of the project’s needs and plans the capacity and capability to enable delivery in a timely and cost-effective manner, always connecting to the needs of the patient.
Leads the effective transition of the supply chain from development into commercialization and at an appropriate time post -Launch, supports opportunities for further innovation on business processes or technologies.
Builds, grows and matures the CMC Project Management function within Technical Operations.
Directs project communications and ensures that all project customers are fully informed and knowledgeable of project activities and their status.
Collaborates with functional leaders to ensure that functional area resources are sufficient to achieve project goals and objectives.
Provides leadership to the team and functional areas to anticipate and identify complex project issues, which pose a challenge to achieving strategic goals. Implements plan to resolve such issues and executes corrective actions.
Evaluates and supports the development of matrix team reports and stakeholders
- Typically requires a BA or BS degree in a technical, engineering or life sciences discipline; an advanced degree in business or in a scientific field is desirable
- Minimum of 10 years of directly relevant experience including participation in cross-functional project management activities; with 3-5 years of experience as a CMC project manager.
- Must have a relevant CMC and supply chain knowledge on developing, manufacturing and industrializing pharmaceuticals along with a thorough working knowledge of the Biotech or Gene therapy industry, relevant regulations and requirements.
- Has led technical transfer activities to manufacturing sites (primary and/ or secondary)
- Has experience leading matrix teams in a Regulated environment
- Has authored CMC sections of CTAs, BLA, MAA
- Inter-company collaborations to develop medicines as part of a strategic alliance or partnership a plus
- Project management certificate a plus.
- Must have a thorough understanding of the drug development process
- Experience in Biotech or Gene Therapy process development and/or product launch preferred
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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